Wildes, Tanya M.

Abstract Background: It was once believed that African-American (AA) patients (pts) with multiple myeloma (MM) had more aggressive disease; however, recent studies suggest that undertreatment rather than biology is responsible for the poorer outcomes observed among AA pts. We recently reported that the utilization of stem cell transplants and bortezomib (BTZ) was 37% and 21% lower, respectively, among AA Medicare beneficiaries from 2000-2010 (Fiala & Wildes, Cancer, 2017). The data suggested that, had AA pts received these treatments at similar rates as their white counterparts there would have been no disparity in outcomes. As they did not, AA pts had a 10% increased risk for death. Lenalidomide (LEN), like BTZ, has become one of the primary treatments for MM since its approval in 2007. However, pts often incur significantly higher out of pocket costs on oral chemotherapies such as LEN compared to injectables like BTZ. Thus, we hypothesized that disparities in utilization of LEN would be greater than in BTZ. Methods: To test our hypothesis, all MM cases from 2007-2013 in the SEER-Medicare were reviewed along with corresponding claims through 2014. We excluded cases with incomplete records including those not enrolled in Medicare Part A, B, and D, and HMO enrollees. We also excluded cases where MM was diagnosed prior to age 65 and suspected cases of smoldering MM, pts who did not receive MM treatment and did not have diagnostic codes for CRAB criteria as previously described (Fiala, et al, under review). The presence or absence of claims for LEN and BTZ within 6 months following MM diagnosis was used to determine utilization. Multivariate logistic regression was performed to analyze the impact of race on LEN and BTZ utilization controlling for age at diagnosis, sex, year of diagnosis, Medicaid enrollment, and previously established algorithms of poor performance status [PS] indicators and Charlson Comorbidity Index [CCI] score. Results: 6,285 cases were included in the analysis. The median age at MM diagnosis was 76 years and 50% were female; 77% of cases were white, 16% were black, and 6% were another race. Overall, the utilization of LEN and BTZ during first-line treatment was 28% and 38%, respectively. In the multivariate model, race was not associated with LEN utilization, but BTZ utilization was reduced by 24% (aHR 0.76; 95% CI 0.65-0.90; p 0.0009) among AA pts. Overall, the models of LEN and BTZ were similar (Table 1). Advancing age, Medicaid enrollment and poor PS were associated with decreased utilization; more recent diagnosis increased utilization. CCI was associated with LEN but not BTZ utilization, sex with BTZ but not LEN. Discussion: We originally hypothesized that LEN utilization would be reduced among AA pts based on increased out-of-pocket costs. However, we and other researchers have shown that traditional access barriers such as insurance and income only account for about 25% of health disparities (Fiala & Wildes, Cancer, 2017). We now hypothesize LEN's oral administration may mitigate some other factors that have been shown to increase disparities such as the preferences and biases of pts and providers. For example, AA pts may prefer oral therapies to a greater extent than white pts. Or AA pts who may decline injectable chemotherapy due to distrust in the medical system may be more willing to accept an oral formulation, or providers who hold an unconscious bias may be more willing to offer one. An alternative explanation could be that AA pts, who tend to have more comorbidities and poorer overall health at MM presentation (Fiala, et al, 2015 ASH abstract 5618), were more likely to be candidates for LEN rather than other treatments. However, we do not believe this is the case as poor PS and increasing CCI were associated with decreased LEN utilization. Conclusions: AA race was associated with reduced utilization of BTZ but not LEN for first-line treatment of MM. These findings do not support our original hypothesis that LEN is associated with a greater disparity in utilization than BTZ due to the higher cost sharing involved with oral chemotherapies. Whether oral formulations mitigate other barriers to treatment such as the preferences and biases among pts and providers requires future study. Disclosures Ailawadhi: Pharmacyclics: Research Funding; Takeda: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Novartis: Consultancy, Honoraria. Vij: Jazz: Honoraria; Konypharma: Honoraria; Celgene: Honoraria; Amgen: Honoraria, Research Funding; Takeda: Honoraria, Research Funding; Abbvie: Honoraria; Janssen: Honoraria; Bristol-Meyers-Squibb: Honoraria. Wildes: Carevive Systems Inc: Consultancy; Janssen: Consultancy.

Abstract Cancer is a disease of aging and, as the world's population ages, the number of older persons with cancer is increasing and will make up a growing share of the oncology population in virtually every country. Despite this, older patients remain vastly underrepresented in research that sets the standards for cancer treatments. Consequently, most of what we know about cancer therapeutics is based on clinical trials conducted in younger, healthier patients, and effective strategies to improve clinical trial participation of older adults with cancer remain sparse. For this systematic review, the authors evaluated published studies regarding barriers to participation and interventions to improve participation of older adults in cancer trials. The quality of the available evidence was low and, despite a literature describing multifaceted barriers, only one intervention study aimed to increase enrollment of older adults in trials. The findings starkly amplify the paucity of evidence‐based, effective strategies to improve participation of this underrepresented population in cancer trials. Within these limitations, the authors provide their opinion on how the current cancer research infrastructure must be modified to accommodate the needs of older patients. Several underused solutions are offered to expand clinical trials to include older adults with cancer. However, as currently constructed, these recommendations alone will not solve the evidence gap in geriatric oncology, and efforts are needed to meet older and frail adults where they are by expanding clinical trials designed specifically for this population and leveraging real‐world data.

PURPOSE To provide evidence-based recommendations on the treatment of multiple myeloma to practicing physicians and others. METHODS ASCO and Cancer Care Ontario convened an Expert Panel of medical oncology, surgery, radiation oncology, and advocacy experts to conduct a literature search, which included systematic reviews, meta-analyses, randomized controlled trials, and some phase II studies published from 2005 through 2018. Outcomes of interest included survival, progression-free survival, response rate, and quality of life. Expert Panel members used available evidence and informal consensus to develop evidence-based guideline recommendations. RESULTS The literature search identified 124 relevant studies to inform the evidence base for this guideline. RECOMMENDATIONS Evidence-based recommendations were developed for patients with multiple myeloma who are transplantation eligible and those who are ineligible and for patients with relapsed or refractory disease.

BACKGROUND/OBJECTIVES The incidence of myeloma in older adults is increasing, yet little is known about geriatric impairments in these patients. We aimed to examine the prevalence of geriatric impairments in older adults with myeloma and the association between geriatric assessment and autologous stem cell transplant eligibility. DESIGN Prospective cohort study. SETTING Two academic medical centers. PARTICIPANTS A total of 40 adults 65 years and older with newly diagnosed myeloma were enrolled. MEASUREMENT Participants completed a primarily self‐administered geriatric assessment, including measures of functional status, comorbidities, polypharmacy, psychosocial status, social support, quality of life, cognition, and physical performance. Outcomes were autologous stem cell transplant eligibility and receipt. RESULTS Forty patients enrolled; their mean age was 71 years. Geriatric impairments were common: 62% reported dependence in one or more instrumental activities of daily living (IADL), 76.9% had polypharmacy (four or more medications), and 47.5% had one or more comorbidities. Median time on the Timed Up and Go was 13.3 ± 4.9 seconds. Those considered candidates for autologous stem cell transplant (N = 26) were younger, with fewer comorbidities, better performance status, and faster performance on the Timed Up and Go test. Factors independently associated with receiving autologous stem cell transplant (N = 21) included age and IADL dependence. CONCLUSION Impairments in geriatric domains are common in this population, even among those considered to have a good performance status. Geriatric assessment domains are associated with both transplant eligibility and receipt. J Am Geriatr Soc 67:987–991, 2019.

e18061 Background: Despite a favorable genetic profile, African-Americans (AAs) with mm have poorer outcomes secondary to inferior treatment. NCI-CCs provide the highest-quality of care and attendance has been associated with better outcomes in many cancers. AAs have greater access to NCI-CCs proximally; however, they attend these facilities at lower rates than their white peers. The impact of attendance at NCI-CCs on mediating racial disparities in mm outcomes has not been reported on to date. Methods: We reviewed cases of mm the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database from 2000-2011 who were enrolled in Medicare Part A and B > 1 year prior to diagnosis, excluding cases enrolled prior to age 65 and those where mm diagnosis occurred post-mortem. Any center designated a NCI-clinical or -comprehensive center in 2002, 2005, or 2010 was considered a NCI-CC; attendance was defined as 2 or more claims on separate dates (MEDPAR and Outpatient files) from a NCI-CC in the 12 months following mm diagnosis. Logistic regression was performed to determine if race was associated with attendance, Cox regression to determine the association of attendance with survival. Results: 21,843 cases were analyzed; the median age was 77 years; 80% were white, 15% AA/Black. Overall NCI-CC attendance was low, only 11% of the population. Compared to white patients, black patients had a 13% decreased odds (aOR 0.87, 95% CI 0.75-0.99) of NCI-CC attendance after controlling for age, gender, socioeconomic status, geographic, and overall health variables. Attendance was associated with a 28% decrease risk for death (aHR 0.72, 95% CI 0.68-0.76), but had little impact on black-white outcome disparities. Black patients had a 9% increase in risk (aHR 1.09, 95% CI 1.04-1.13) after controlling for NCI-CC attendance. Conclusions: Black patients with mm have lower NCI-CC attendance. This may be related to referral bias and/or patient declining referral. NCI-CC attendance was associated with superior outcomes; however, controlling for attendance did not mediate black-white outcome disparities suggesting that racial treatment disparities pervade beyond access to NCI-CCs.